Medical Device
A Medical Device is a device that is intended to be used in a medical task.
- Context:
- It can range from being a Medical Therapautic Device to being a Medical Instrument Device.
- It can range from being a Validated Clinical Device to being an Un-Validated Clinical Device.
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- Example(s):
- Medical Monitor Devices, that allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other parameters including ECG, EEG, and blood pressure.
- Medical Diagnostic Devices, that can include medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines.
- Medical Treatment Devices, that can include infusion pumps, medical lasers and LASIK surgical machines.
- Life Support Devices that can maintain a patient's bodily function. This includes medical ventilators, incubators, anaesthetic machines, heart-lung machines, ECMO, and dialysis machines.
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- a Wearable Medical Device such a Heart Rate Sensor.
- a Biomarker Device such as a blood glucose meter.
- a Cardiac Pacemaker.
- a Software as a Medical Device.
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- Counter-Example(s):
- Medical Drug, such as a vaccine.
- See: Remote Patient Monitoring (RPM) System, Medical Software, Biomedical Engineering, Medical Device Regulation, Medical Device Development Clinical Trial, Wearable Medical Device, Investigational Device Exemption (IDE) Program, Early Feasibility Studies (EFS) Program.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Medical_device#Types Retrieved:2022-12-2.
- There are several basic types:
- Diagnostic equipment includes medical imaging machines, used to aid in diagnosis. Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines.
- Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines.
- Life support equipment is used to maintain a patient's bodily function. This includes medical ventilators, incubators, anaesthetic machines, heart-lung machines, ECMO, and dialysis machines.
- Medical monitors allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other parameters including ECG, EEG, and blood pressure.
- Medical laboratory equipment automates or helps analyze blood, urine, genes, and dissolved gases in the blood.
- Diagnostic medical equipment may also be used in the home for certain purposes, e.g. for the control of diabetes mellitus
- Therapeutic: physical therapy machines like continuous passive range of motion (CPM) machines.
- The identification of medical devices has been recently improved by the introduction of Unique Device Identification (UDI) and standardised naming using the Global Medical Device Nomenclature (GMDN) which have been endorsed by the International Medical Device Regulatory Forum (IMDRF).
A biomedical equipment technician (BMET) is a vital component of the healthcare delivery system. Employed primarily by hospitals, BMETs are the people responsible for maintaining a facility's medical equipment. BMET mainly act as an interface between doctor and equipment.
- There are several basic types:
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Medical_device Retrieved:2021-6-2.
- A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017 the Medical Device Regulation (MDR) replaced the MDD. Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering. The global medical device market reached roughly US$209 billion in 2006 and was estimated to be between $220 and US $ 250 billion in 2013. The United States controls ~40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has a larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share.
- A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.